Otc - Active Ingredient
Active ingredients
Dextran 70 0.1%
Polyethylene glycol 400 1%
Povidone 1%
Tetrahydrozoline HCl 0.05%
Topcare Health Advanced Moisturizing Plus Redness Relief Solution
FDA Label NDC 36800-856
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Health Advanced Moisturizing Plus Redness Relief (NDC 36800-856). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Dextran 70... Lubricant
Polyethylene glycol 400... Lubricant
Povidone... Lubricant
Tetrahydrozoline HCl... Redness reliever
Indications & Usage
Uses
- relieves redness of the eye due to minor eye irritations
- as a lubricant to prevent further irritation or to relieve dryness of the eye
Warnings
Warnings
For external use only
Otc - Ask Doctor
Ask a doctor before use if you have narrow angle glaucoma
Otc - When Using
When using this product
- pupils may become enlarged temporarily
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using
- if solution changes color or becomes cloudy, do not use
- overuse may produce increased redness of the eye
- remove contact lens before using
Otc - Stop Use
Stop use and ask a doctor if you experience
- eye pain
- changes in vision
- continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
Directions
Instill 1 to 2 drops in the affected eye(s) up to 4 times daily.
Other Safety Information
Other information
store at 15°-30°C (59°-86°F)
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride
Package Label.Principal Display Panel
Carton (Topcareadvancedrel Cedar0051tr3)
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